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Health Canada Medical devices

COBAS EGFR MUTATION TEST V2

Issued November 26, 2021
Issue
Roche received few complaints from customers reporting the generation of false mutation detected results for the Exon 20 insertion (EX20INS) mutation when using the Cobas EGFR mutation test V2. Recall start date: 2021-09-15
Hazard description
Inaccurate test or measurement results
Product
Product name
COBAS EGFR MUTATION TEST V2
Reference
ID
RA-63663